Medical Device ISO13485 auditor/ assessor(homebased)

Medical Device ISO13485 Auditor/Assessor (Homebased) Great that you're thinking about a career with BSI! Medical Device Assessor Singapore - Homebased, Travel Required, Local Hire As a Medical Device Auditor, you'll travel to medical device manufacturers across APAC. You'll help these manufacturers improve their performance by assessing their ISO 13485 quality management system, ensuring patient safety and compliance with regulatory procedures. In the first six months of being a Medical Device Auditor, you'll: Receive training in ISO 13485 Lead Auditor training, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation). Initially observe how audits are conducted but then grow to conduct them on an individual basis on-site at medical device manufacturers across APAC and remotely from your home office. In a typical week after being fully trained, you'll: Conduct an audit on-site or remotely. Write up your reports and liaise with the planning team to manage your audit schedule. Continue your development of MDR and advocate for the ISO 13485 APAC Delivery Team. To thrive in this career, you must: Have 4 years or more of direct accountability for the design, testing, or manufacture of different medical devices. Experience with Active Medical Device R&D is mandatory; software experience is preferred. Be degree educated in a discipline relevant to Medical Devices (e.g., chemistry, physical chemistry, molecular genetics, textiles, material science, biology, biotechnology, or similar). Have at least 2 years' experience working in an environment with an established Quality Management System. Speak and write fluently in English. Be resilient and able to meet audit delivery by traveling frequently across the APAC region as required. Hold Singapore EP or be a Singapore citizen. We're enthusiastic to receive applications from those based in Malaysia excited by this career opportunity. Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI, ensuring that BSI is a great place to work and a highly successful business. #J-18808-Ljbffr